This article has been updated to include a statement from Myriad Genetics.
NEW YORK (GenomeWeb) – Law firm Sterne, Kessler, Goldstein & Fox announced today it has filed petitions for Inter Partes Review (IPR) with the US Patent and Trademark Office on behalf of its client GeneDx, which is seeking to nullify patents held by competitor Myriad Genetics related to gauging cancer risk based on mutations in three genes: BRCA1, BRCA2, and MUTYH.
Last October, Myriad and other co-owners of 16 patents underlying its hereditary cancer risk tests filed a suit against BioReference Laboratories' subsidiary GeneDx, alleging the firm was infringing its IP. "Myriad is attempting to prevent GeneDx and others from conducting tests involving these genes to identify the molecular basis of inherited cancer," Jorge Goldstein, director at Sterne Kessler, said in a statement. "These IPR filings by GeneDx are the first, and so far, only use of the novel IPR procedure by any of the defendants in the Myriad litigation."
The 11 patents owned, co-owned, or licensed by Myriad that are now being challenged by GeneDx through the IPR petitions include U.S. Patent Nos. 5,654,155; 5,753,441; 6,033,857; 6,051,379; 6,083,698; 6,951,721; 7,470,510; 7,563,571; 7,622,258; 7,670,776; and 7,838,237. Myriad, in its case against GeneDx in the US District Court for the District of Utah, alleged the firm was infringing claims in these patents.
GeneDx is countering by filing IPR petitions and challenging the validity of these patents at the USPTO, alleging that they claim prior art – information that was made public about an invention before a particular date. Meanwhile, the ongoing court case between GeneDx and Myriad will continue to evaluate these patents claims in the context of subject matter eligibility (ie. is the claimed invention a process, machine, manufacture or composition of matter, with the exception of laws of nature, physical phenomena, and abstract ideas). The IPR proceedings – which are procedures established by the American Invents Act of 2011 – will take place in parallel with the court case, but may result in a faster decision, according to Sterne Kessler.
"The use of IPRs as a parallel procedure in patent litigation is a proven method to deal with highly technical issues involving prior art because the USPTO has expertise in adjudicating technical matters," Eldora Ellison, director at Sterne Kessler, explained in a statement. "IPR is an accelerated procedure typically completed within 18 months of filing; and in contrast to invalidation challenges in federal court, the burden of proof on the challenger is by a preponderance of the evidence, not by clear and convincing evidence. Finally, the patents are not presumed valid at the USPTO during an IPR as they are in federal court."
Myriad filed lawsuits last year against firms that began offering testing services gauging BRCA mutations after the US Supreme Court decided in Association for Molecular Pathology et al. v Myriad that several of its patent claims on isolated BRCA sequences were patent ineligible, while its claims on cDNA were patent eligible. Myriad maintains that its suite of still valid patents, as well as the Supreme Court's ruling, protects its cancer risk testing IP from these other firms.
GeneDx and six other providers of cancer testing engaged in lawsuits with Myriad disagree, and have attempted various strategies. Some labs, such as Quest, for example, have tried to preempt Myriad by suing the Utah-based company first, while other shops, such as InVitae, have countersued Myriad, seeking declaratory judgment in their own legal jurisdictions.
In one of Myriad's cases against Ambry Genetics, the US District Court for the District of Utah in March denied Myriad's and other patent holders' request for a preliminary injunction against Ambry to stop it from performing and selling tests that gauge BRCA genetic mutations. However, the court hasn't yet ruled on the merits of the patent claims at issue in the case. Meanwhile, Gene by Gene – another testing firm that launched BRCA testing after the Supreme Court's ruling in AMP v. Myriad and was sued by Myriad – settled the dispute out of court.
According to GeneDx, it is the first company to attempt to invalidate the patents claims at issue with Myriad using the IPR pathway.
"We continue to believe that our patents are valid and enforceable," Myriad spokesperson Ron Rogers said in a statement to GenomeWeb Daily News. "We will defend our patents and believe that we'll prevail based on the weight of the evidence."